A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT05372354
This study evaluates the safety and preliminary effectiveness of CC-92480 in combination with Tazemetostat, BMS-986158, Trametinib, and Dexamethasone for treating RRMM. Eligible participants must have relapsed or refractory MM, documented disease progression, measurable disease, and an ECOG PS of 0 or 1. Participants must adhere to the CC-92480 Pregnancy Prevention Plan.
Patient Parameters
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Program Overview
The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).
Eligibility Criteria
Inclusion Criteria
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Relapsed or refractory multiple myeloma (MM) and must:
- have documented disease progression during or after their last myeloma therapy
- be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM
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Must have measurable disease
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Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
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Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP)
Exclusion Criteria
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Known active or history of central nervous system (CNS) involvement of MM
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Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis.
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Impaired cardiac function or clinically significant cardiac disease
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Previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomatic infections or 28 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1)
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For Part 1: received prior therapy with CC-92480
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For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, or trametinib
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Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment
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Received any of the following within 14 days prior to initiating study treatment:
- Plasmapheresis
- Major surgery
- Radiation therapy other than local therapy for myeloma associated bone lesions
- Use of any systemic anti-myeloma drug therapy
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Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment
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COVID-19 vaccine within 14 days prior to C1D1
Other protocol-defined inclusion/exclusion criteria apply
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